Friday 29th January 2021
Hungary simplifies emergency approval
Orban waves Sputnik and Sinopharm through
While the EU countries are suffering from scarce vaccine quotas, Hungary's head of state Orban is taking an unusual approach to procurement. Vaccines from Russia and China should get the green light through emergency approval. The own authorities are sidelined, concerns ignored.
The Hungarian Prime Minister Viktor Orban has simplified the emergency approval of corona vaccines from Russia and China by ordinance. In particular, it will in future be possible to use the vaccine in Hungary under certain conditions without the company's own drug and health authorities carrying out a separate inspection.
The regulation, which appeared in the Hungarian Official Journal on Thursday, provides for an automatic mechanism if the following conditions are met: firstly, the vaccine in question is already approved either in the EU or in Great Britain or is being used in at least three countries, one of which is an EU member state or EU candidate country is administered to the population; and second, a million people have already been vaccinated with the drug in question. The complicated formulated conditions are tailored to vaccines from Russia and China, with which many people have already been immunized. Above all, the Hungarian emergency approval is also making massive use of the EU candidate country Serbia, which would meet the first condition.
Reviewers have concerns
Last week, Hungary was the first EU country to order two million doses of the Russian preparation Sputnik V. So far, one of two Hungarian authorities has issued the emergency license. In the meantime, it became clear that external reviewers had expressed concerns about deficiencies in the documentation of the clinical tests. Orban also plans to buy and use large quantities of the Chinese vaccine Sinopharm. The vaccine has not yet received an emergency approval in Hungary. In terms of the new regulation, this could now be done practically automatically.
The Hungarian government is extending the partial lockdown that has been in effect since the beginning of November until March 1. This means that the protective measures, which are actually limited until Monday, such as the night curfew and the closure of secondary schools and restaurants, remain in place. This was announced by Prime Minister Viktor Orban's chief of staff in the afternoon. The measures did help slow the spread of the virus and keep it under control, says Chief of Staff Gergely Gulyas. Due to the shortage of vaccines, however, a loosening would lead to a new wave and ultimately to more drastic restrictions.
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